Not only has the way the courts decide claims for the provision of health care changed significantly over the last 30 years, but health care rationing in the NHS has also evolved from implicit to being increasingly explicit “about what” and “about why and how” during the same period.
The distinction between the two aspects of explicit rationing – “about what” and “about why and how” – is important (although not always clearly made in the literature) because both aspects of explicitness do not necessarily come together. The public may be aware of which treatments are not being provided to patients (“explicit about what”), but without the reasons or the procedure through which these decisions are reached being disclosed (“explicit about why and how”).
As will be seen in this section, explicit rationing “about what” is not immediately or necessarily followed by explicitness “about why and how”. Being explicit “about why and how” is a policy choice. This distinction also allows a more precise account of the different stages in the process from implicit to explicit rationing in the NHS and of the role played by the heightened judicial scrutiny in making rationing more explicit – in both senses – in the NHS.
The impact of the courts on administration is not always easy to establish. Whilst it can be clear when certain bureaucratic changes are ordered by a court or when a policy is admittedly aimed at responding to a judicial decision or a group of decisions, there are other forms of impact that are more difficult to determine. Some changes are not provoked by the outcome of a judicial decision per se, but by what the courts say and the publicity brought by a particular case.
Moreover, the impact can also be diffuse and influence the less accessible aspects of an administration learning to live with the shadow of judicial review, such as the internal and informal working practices of departments and their decision-making culture.
Most of the impact courts have had on health care rationing is of the kind that is more difficult to determine. However, by focusing on two landmarks cases – Child B
– it is possible to show that the impact exists and that it is relevant. Child B contributed to bringing the public's attention to the fact that rationing was occurring in the NHS and it also made health authorities aware that they now had to set priorities with the judges over their shoulders. Pfizer alerted the NHS that it needed a national system for making the assessment of health technologies more informed and consistent in order to avoid and respond to litigation. These two landmark cases, coupled with subsequent judicial decisions, created incentives for important institutional reforms and there is evidence that the courts’ rulings have been shaping the decision-making process in the NHS.
It is important to clarify that this article is not claiming any strong causal relation in the sense of arguing that litigation has been a sufficient or a necessary condition for the changes in health care rationing in England. As previous research on the impact of litigation on bureaucracies has indicated, it is very difficult to isolate the role of courts and estimate their independent impact because policymakers are continuously reacting to multiple pressures.
What is possible to show, however, is that courts interacted within a “soup of influences” that created a context that made rationing more explicit “about what” and that, through their rulings, they established a continuous policy dialogue with decision-makers in the NHS that contributed to make rationing explicit “about why and how”.
A. From Implicit to Explicit “About What”
The NHS, like any other health care system in the world, has always had to restrict access to health care for cost reasons. For many years, this restriction took the form of implicit rationing. Rationing decisions were mostly hidden in clinical appraisals made by practitioners who, aware of the budgetary constraints, have told patients that nothing more could be done to benefit their health, rather than by saying explicitly that a treatment could not be provided because resources were not available or were to be used for other priorities.
Thus, for many years, through a technocratic paternalism grounded in a “deep reservoir of deference to doctors”, the NHS managed to dampen down patients’ expectations and maintain implicit rationing.
This implicit rationing scheme started to become unsustainable in the 1990s. One of the reasons was the health reform that created a provider-purchaser split and introduced an internal market into the NHS. This led to an uneven provision of care as the access to some treatments depended on the patients’ catchment area rather than on their needs alone – the so-called “postcode lottery”. This made the public aware that the basket of treatments available to patients was not based solely on clinical reasons, but was also a matter of policy choice and priority-setting.
In addition, the menu of technological possibilities in health care began expanding exponentially in recent decades. Health conditions that were once considered untreatable are now finding suitable treatments as a result of the development of costly new medical technologies.
This scientific progress, coupled with its marketing and media coverage, has coincided with an ageing society of more educated and better-informed citizens (notably with the advent of the Internet) with higher expectations of being treated with the latest and best that the medical science can offer.
In England, the role of the media has also been particularly relevant with stories of health care rationing presented in a “melodramatic style”, which, whilst very rare in the 1980s, started to represent a constant source of public pressure on the NHS from the 1990s onwards.
In sum, patients have become more aware of what they could have and of what they were denied by the NHS. They have also become more assertive in demanding doctors and the health system to make use of these new technologies, including through litigation.
However, courts have not been merely reflecting the change in the way rationing has been carried out in the NHS. As already suggested by the socio-legal literature, judicial decisions are influenced by the very context that they help to create
and, if there is a court case to be singled out in this respect, it is Child B.
Child B was the first health care rationing case to receive the attention of the mass media and this gave explicit rationing “about what” an extraordinary visibility. Child B contributed to lifting the veil of implicit rationing for the public and started an unprecedented national debate about rationing, which greatly increased the pressure on authorities and politicians. Without the judicial dispute, the child's drama would arguably have passed unnoticed by the media and public opinion. Instead, the legal case was on the front pages of all the national newspapers, was the subject of many editorial comments, and also covered prominently on television.
The fact that the media coverage was often critical of the health authority also contributed to weaken the public's trust in the decisions made by the health system.
Commentators have also noticed that the repercussion of this court case made rationing more visible to the public and increased the interest of the media in broader discussions about priorities and the allocation of resources within the NHS.
Moreover, Child B sparked an academic debate on rationing and priority-setting in the NHS, as can be seen by the vast health policy literature cited in this article that focuses on understanding this case, its repercussions and trying to draw lessons from it. After the end of the legal dispute, and in contrast with the then usual reluctance to admit the existence of rationing, the defendant authority justified its decision stating that rationing is “necessary” and “legitimate”, and that it should be done explicitly rather than behind closed doors.
Child B not only made rationing “about what” more evident to the public, but it also made patients more aware that judicial review is possible. Qualitative research into cases of contested funding decisions soon after Child B showed that not only were decision-makers in the NHS concerned about the possibility of judicial review, but also patients had become more willing to go to court or at least to invoke the threat of legal action to put pressure on health authorities to reconsider their decisions not to fund a treatment.
One interesting example is a letter sent by a solicitor to a health authority informing that she/he had advised the patient to apply for judicial review against the decision not to fund a treatment, and mentioning that similar cases had already been granted leave.
Child B shows that the impact of a court case can go way beyond the judgment per se. The final decision by the Court of Appeal was overshadowed by the wide public, academic and political debate about rationing in the NHS that this case provoked. It has also made health authorities aware that their priority-setting decisions have become more visible and thus were more likely to be scrutinised both inside and outside the courtroom.
B. From Explicit “About What” to Explicit “About Why and How”
The visible mismatch between patients’ expectations and the level of care the NHS is capable of providing has undermined the equilibrium that had previously sustained an implicit rationing system. Authorities and politicians began to face the dilemma of choosing between the ever-heavier financial costs of providing new and expensive treatments or the ever-greater political costs of not providing them, or perhaps having to bear both costs at the same time.
The NHS response to the challenges brought about by explicit rationing “about what” was to make health care rationing “explicit about why and how”. Explicit rationing about “why and how” started with the efforts of health authorities to demonstrate that they had been rigorous and fair in arriving at their decisions. This led to greater involvement of external advisors, the establishment of scientific committees to provide better scientific evidence, and attempts to apply an explicit priority-setting framework with clear and standardised criteria against which services and treatments could be assessed.
The Department of Health also showed a growing enthusiasm for evidence-based medicine in order to identify and exclude procedures and treatments that were not cost-effective.
In 1994, the NHS Management Executive's Value for Money Unit urged health authorities to base their purchasing decisions on evidence of clinical effectiveness.
The case of Child B made it even clearer for health authorities that they were likely to be severely scrutinised by courts and the public and, hence, that they had to show that their decisions had been fair, transparent and based on rigorous assessment of the evidence. It also indicated that the NHS needed improvements in the existing procedures for priority-setting in order to deal with future cases. Ham and McIver
interviewed health authorities involved in rationing decisions after Child B to assess the changes in their decision-making process following this case. The conclusion was that Child B, the then recent judgment in Fisher,
and the constant threat of judicial review have contributed to make authorities aware that they were expected to provide better reasons to justify their decisions. In some of the cases discussed in this research, the more frequent involvement of lawyers in disputes about funding and the threat of judicial review resulted in authorities reconsidering its policy and occasionally revising its decision to avoid litigation.
Authorities have also realised that, to be able to provide better reasons, they needed an evidence-informed, transparent and consistent decision-making process. This, according to the interviewees, resulted in the establishment of committees for dealing with rationing decisions, the advice of independent external specialists, the search for more evidence and a more detailed look at it, a deeper understanding of the ethical issues involved, the adoption of appeal procedures, and more explicitness about the criteria against which the treatments demanded should be assessed. In sum, finding reasons that would be acceptable to both the courts and the public to safeguard their decisions from legal challenge had become a permanent concern among health authorities after Child B.
This case also prompted an academic debate about the role of the courts in assessing this kind of case. Many commentators criticised the Court of Appeal's decision for not demanding from the health authority better reasons for not funding a lifesaving treatment and for not engaging with the High Court's argument that a reported scarcity of resources was not enough to justify a rationing decision.
Child B, and the court cases that followed it, showed health authorities that rationing had to be more explicit “about why and how”, but also that they needed support from the central government to do so in the form of expertise and guidelines to make complex priority-setting decisions. At that time, health authorities at local level did not have much information available on the cost-effectiveness of treatments and they lacked expertise in producing evidence-based decisions. This resulted in inconsistent decisions, in the failure to provide sufficient evidence for restricting access to treatments, or in the unsatisfactory quality of the evidence provided.
For instance, the then Chief Executive of the Cambridge Health Authority (the defendant authority in Child B) complained about the “invidious position” of having to make difficult decisions without any guideline.
A sophisticated health technology assessment depends on high levels of scientific and economic expertise and is time and resource consuming. It would be too burdensome for each local health authority to provide a comprehensive and well-documented assessment of each new health technology. This would lead to unnecessary duplication of efforts and to an overall confusion and inefficiency in the system. The use of ambiguous, obscure or conflicting criteria by different health authorities when assessing competing claims on resources did not help to avoid financial, political or judicial pressure on the health system caused by explicitness “about what”. The fact that treatments were unevenly purchased by different but adjacent health authorities not only showed that health care was being rationed but also that health authorities lacked consistent criteria for priority-setting.
The NHS needed a stronger lead from the centre to make rationing decisions, coordinate technology information analysis and create nationally agreed standards.
The first case in which the Department of Health attempted to lead from the centre was the decision not to fund Viagra in the NHS other than in exceptional circumstances. The effectiveness of Viagra was not in doubt and the Department of Health justification for restricting the provision of this drug was the cost of the treatment and its affordability for the public health system. This was considered an important landmark in the history of the NHS because it showed for the first time that central government recognised the inevitability of rationing and that it was grappling publicly with the problem.
This policy, however, was criticised because there was no clear set of evidence-based reasons for rationing Viagra, and the pharmaceutical company Pfizer filed a lawsuit on this same ground.
The High Court required reasons in the form of objective and verifiable criteria for restricting the provision of a treatment, which the Government could not provide. The controversy around this case and the decision of the High Court in favour of the claimant showed that rationing decisions at the national level also had to be grounded on a fair procedure, solid evidence and consistent policy reasons.
In other words, the “lead from the centre” required not only central decisions being explicit “about what”, but also “about why and how”. Arguably, a “NICE-like” procedure was then necessary to justify the ban on Viagra, although at that time NICE was “still nothing more than a policy dream”.
At the end of the 1990s the Department of Health issued two consultation documents putting forward a strategy to deal with the need to improve the quality of care and the challenges raised by an increasingly explicit rationing: The New NHS: Modern and Dependable
and A First Class Service: Quality in the New NHS.
These documents affirmed that the NHS was “facing more challenges than ever”, resulting from, amongst other things, greater and faster medical advances; a better-informed and more demanding public; an ageing population; low public confidence in the NHS prompted by the “postcode lottery”; a lack of any coherent assessment of which treatments worked best for patients; and the NHS having never been sufficiently open or accountable about the quality of its services. These documents proposed that decisions should be based on the best possible evidence and that the Government should provide new tools for tackling these challenges.
The proposal for the creation of the then called National Institute for Clinical Excellence (NICE) was set out in these documents based on the idea that high quality and cost-effectiveness are two sides of the same coin.
NICE was aimed at creating a coherent national system for the appraisal of new technologies in substitution for the plurality of bodies that had been carrying out this kind of analysis with different methods, variable quality, and sometimes duplicating each other's efforts and creating confusing evidence unlikely to be helpful to clinicians or authorities.
NICE was eventually established in 1999 in political recognition that a centralised, national, rational and transparent mechanism for setting priorities was necessary in face of the advance in new and expensive health technologies.
NICE is responsible for carrying out health technology appraisals – guidelines on the use of health technologies based on clinical and cost-effectiveness analysis – a task that, due to its complexity, frequently generates scientific and moral disagreement. The institute is also frequently under political pressure because a NICE decision appraisal not recommending a treatment will restrict patients’ access to it in the NHS.
It is thus necessary that NICE appraisals be legitimate. This was intended to be achieved by an emphasis on “procedural justice” in NICE, which means that “the processes by which health care decisions are reached are transparent, and that the reasons for the decisions are explicit”.
According to Michael Rawlins
(NICE's first chairman) and to NICE itself,
procedural justice in NICE follows Norman Daniels’ idea of “accountability for reasonableness”
and explicitly encompassed its four conditions:
Publicity: decisions on the allocation of resources and the grounds for reaching them must be made public;
Relevance: the grounds for the decisions must be relevant and acceptable by fair-minded people;
Challenge and revision: the procedure should offer opportunities for challenging decisions and a transparent system should be available for revising decisions if new evidence becomes available;
Regulation/Enforcement: NICE has to be accountable to the public for its reasonableness in order to guarantee that the first three conditions are met.
Procedural justice in NICE is reflected in the transparency of the decisions and of the reasons that back them up (publicity); the scientific rigour in the analysis of the evidence and consideration of social values and equity (relevance); and the right of stakeholders to be consulted and to challenge the decisions, which can then be revised to incorporate new evidence (challenge and revision). In addition, as shown in the previous section, courts have scrutinised the decision-making process in NICE to guarantee that the first three conditions are met (regulation/enforcement).
In a context in which fair-minded people may disagree about which principles of justice should guide the allocation of health care resources, “accountability for reasonableness” offers a solution of procedural justice to the problem of making rationing decisions fair and legitimate from the perspective of those whose health needs were not met, as well as the public and (at least in England) the courts.
The decision of the High Court in Pfizer was almost concurrent to the establishment of NICE and some commentators suggest a direct association between this case and the creation of the institute.
NICE itself has identified Pfizer as one the main drivers for its creation because the case showed that the Government was vulnerable to questions about the “ad hoc and opaque fashion in which decisions were made” while trying to centralise rationing decisions to attempt to avoid the problem of the “postcode lottery”.
NICE had come into existence by the time of the Court of Appeal decision in Pfizer but, interestingly, the Government did not refer Viagra for its assessment. Arguably, this was because the Government was afraid that a favourable appraisal by NICE would increase the pressure to supply Viagra.
Instead, the Government's litigation strategy was to insist that this case was a problem of affordability rather than of cost-effectiveness and, successfully, relied on a more deferential attitude from the Court of Appeal. The pharmaceutical company, on the other hand, argued that decisions about the funding of drugs should be based on “cost-utility analysis”, which the Government had not carried out. Whilst the Court of Appeal mentioned NICE in its decision as offering a comprehensive and empirically based framework for the adequate analysis of new technologies, it accepted the arguments of the Government without close scrutiny of this particular policy.
Like in Child B, even though the High Court's heightened scrutiny was eventually overturned by the Court of Appeal, the Pfizer case had an impact that went far beyond the final outcome of the litigation. In most of the subsequent judgments, courts were willing to scrutinise the process and the reasons for a rationing decision, including of those made by NICE.
In this section, the cases Pfizer and Child B were singled out for a deeper analysis, but this is far from meaning that these are the only relevant cases for understanding the impact of litigation on rationing. The continuous use of litigation to challenge rationing decisions and the increasingly heightened scrutiny by courts over the years have contributed to creating enduring changes in the way rationing decisions are made in the NHS. The courts’ requirements in judicial review are now integrated in the NHS decision-making processes for deciding on the provision of health care.
A survey of how health authorities make allocative decisions and set priorities identified the risk of judicial review as one of the reasons that justify the effort of making priority-setting decisions more explicit.
According to the preface to this research, “The exacting nature of the financial challenge facing the National Health Service (NHS), combined with increasing demand for NHS services, means that commissioners will have to make difficult decisions about how NHS resources are used. Processes for reaching and enacting these priorities will need to be robust and transparent, and capable of withstanding judicial review”.
It has also become common for lawyers and legal scholars to give presentations and write papers aimed at NHS staff explaining what judicial review is, helping to interpret judicial decisions, and providing guidance on how decisions should be made in order to prevent litigation or to avoid having decisions quashed by the courts. The advice includes recording and providing reasons in order to show that each case has been considered in a comprehensive and attentive way.
Following judgments quashing the blanket ban of treatments and requiring exceptional individual circumstances to be considered, health authorities have established Exceptional Case Panels to assess individual funding requests (IFRs) for treatments which are not routinely funded for all patients.
In the document that provides guidelines for health authorities to consider IFRs, it is stated that authorities “must be able to explain coherently their decisions to clinicians, patients, the public, and the courts”.
Additionally, throughout the document there are concerns about what the courts might think of decisions made by health authorities and how to proceed in such a way as to lessen the risk of having decisions reviewed by judges. It is even recommended that the health authorities act in a judicial-like way when analysing administrative appeals, using the same tests that courts apply to scrutinise their decisions.
The Department of Health has recommended that health authorities give written justification to patients who are denied a certain treatment, clarifying the reasons for the decisions; that these decisions be grounded on robust evidence and consistent criteria; and that the procedure and rationale for each decision be documented.
Moreover, the primary decision-makers’ duties of transparency, fairness and justification, which were imposed by the courts, have become rights to which the NHS itself states that patients are entitled.
The NHS Constitution, which Newdick considers the reflection of principles developed by a decade of judicial review,
declares that patients have the right to expect local decisions on funding be made rationally following a proper consideration of the evidence and that decisions not to fund a drug or treatment must be justified.
In conclusion, a heightened judicial scrutiny has pushed the NHS to ration health care in a way that is along the lines of “accountability for reasonableness” in order to avoid, respond to and comply with judicial review. These changes in the administrative decision-making reflect the fact that the denial of funding for a health intervention will hardly ever be upheld by courts if the decision and the grounds for it are not made public (“publicity”), based on sound evidence and reasonable policy considerations (“relevance”) and if the opportunity for adequately challenging the policy or presenting a case for an exception is not given (“challenge”). Accordingly, the courts are guaranteeing that health care rationing decisions in the NHS will comply with the first three conditions for “accountability for reasonableness” and are thus materialising the last condition (“regulation/enforceability”).